Ottava at United States

Johnson & Johnson (NYSE: JNJ; founded 1886, New Brunswick, New Jersey), through its MedTech and Ethicon division, is developing Ottava, a soft-tissue general-surgery robotic platform with a unified architecture of four arms integrated into the operating table, announced in 2020 and repeatedly delayed. The critical audit finding is that as of mid-2026 Ottava is pre-market: J&J submitted it to the FDA via a De Novo classification application on January 7, 2026 for multiple upper-abdomen general-surgery procedures, and the company's own language states it is under development and not authorized to be marketed or sold in any market.

Investigational first cases were completed in early 2025 at Memorial Hermann in the Texas Medical Center, with a second investigational study for inguinal hernia approved in late 2025. The registry records Ottava at research maturity, because under the verified-vs-claimed framework no regulatory clearance means research-tier regardless of corporate scale or demonstrations, and Ottava has no clearance and zero installed base, only investigational-trial cases.

An aggregator claim that Ottava was targeted for commercial launch in late 2025 or early 2026 is contradicted by the primary J&J source and is not registered. For context, J&J's separate Monarch robotic bronchoscopy, acquired through Auris in 2019, and its Velys robotic knee-replacement system are already FDA-cleared commercial products, but Ottava is the soft-tissue surgical-robot entity and remains pre-market.